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The MDI SS-B Test reagents (P/N; SBKi-G) are intended for the semi-quantitative determination of IgG antibodies to SS-B in human serum. The principal diagnostic value of this test is detection of autoantibodies, which are used as an aid in patients with rheumatoid diseases.
The MDI SS-B Test is a semi- quantitative Enzyme Immunoassay (EIA) Kit for the detection of auto- antibodies against human SS-B in human serum The test is intended as an aid in the diagnosis of rheumatic diseases. FOR IN VITRO DIAGNOSTIC USE ONLY.

The Micro Detect, Inc. SS-B reagent ( MDI SS-B Test) is intended to be used as a manual procedure. The reagents are supplied as a micro plate coated with specific antigens and Controls. Wash Buffer. Sample Diluent, Conjugate, Substrate, and Stop Solution.

The provided document describes the MDI SS-B Test, an in vitro diagnostic device, and its performance. Here's an analysis based on your requested categories:

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document implies these performance metrics were deemed "substantially equivalent" to predicate assays, which serves as the implicit acceptance criteria.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "The patient results obtained using the MDI SS-B Test is substantially equivalent to those obtained by using predicate assays," which describes the type of comparison made.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Autoantibodies are typically identified through laboratory methods, not expert consensus in the same way an image interpretation might be.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This type of in vitro diagnostic device relies on laboratory assay results, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., medical imaging), not for an in vitro diagnostic test for autoantibodies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is an in vitro diagnostic device, meaning its performance metrics (sensitivity, specificity, precision) are inherently standalone; they represent the performance of the assay itself without human intervention in the result generation or initial interpretation. The "manual procedure" mentioned refers to the laboratory technician performing the steps of the assay, not interpreting an image or complex data requiring AI.

7. The Type of Ground Truth Used

The ground truth for an in vitro diagnostic device like the MDI SS-B Test would typically be established by:

• Clinical Diagnosis: A definitive clinical diagnosis of a rheumatic disease based on a comprehensive assessment (symptoms, other lab tests, physician evaluation).
• Reference Method/Predicate Device: Comparison to a well-established and validated reference method or a predicate device that is already cleared for similar use. The document explicitly states "substantially equivalent to those obtained by using predicate assays," indicating comparison to predicate device results as part of the ground truth establishment.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is expected as the MDI SS-B Test is an immunoassay kit, not a machine learning or AI-based device that typically requires a training set for algorithm development.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable in this context.

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